Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
Clinical/Medical
Blue Ridge Beef Issues a Recall of Blue Ridge Beef Natural Mix Due to Salmonella Contamination
January 31, 2025– Blue Ridge Beef is recalling 5,700 lbs. of their 2 lb log Natural Mix due to a…
Supply chain outlook 2025: Key trends and risks to follow
The industry expects another year of geopolitical turmoil, severe weather and pricing pressure. Here’s what you should know.
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment
Clinical / Medical
Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
Shortages 2025: Geopolitics, severe weather fuel uncertainty
Tariff threats, lingering storm impacts and regulatory uncertainty are creating challenges for supply in the automotive, medical and food sectors.
Premarketing Risk Assessment
Guidance for Industry – Premarketing Risk Assessment, Clinical/Medical
Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy
Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide…